A Study of All-Trans Retinoic Acid (ATRA) and Bryostatin in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS)

• Status: Completed
• Trial end date: 2000-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the effects of the combination of all-trans retinoic acid in combination with one of two schedules of Bryostatin 1 in patients with myelodysplasia and acute myelogenous leukemia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborator: Brigham and Women's Hospital
• Treatments: Bryostatin 1; Tretinoin

Criteria

Inclusion Criteria:

• Patients with AML who have failed induction chemotherapy.

• Patients with secondary AML

• Patients with AML over age 60 who are deemed not to be a candidate for chemotherapy.

• Patients with any subtype of MDS.

• Age 18 or greater.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• Satisfactory liver and kidney function.

• Greater than 4 weeks from prior chemotherapy or radiation therapy.

Exclusion Criteria:

• Central nervous system abnormality.

• Uncontrolled active infection.